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ASEAN GMP TRAINING MODULE
INTERNAL AUDIT
Prepared by:
Lam Kok Seng - Singapore
Approved by:
ASEAN Cosmetics GMP Team
Endorsed by:
ASEAN Cosmetic Committee
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CONTENT OF PRESENTATION
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TABLE OF CONTENT
European Committee
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a. Introduction
 Objectives
 Description of Internal Quality Audit
 Scope of IQA
 Benefit of IQA
 The key principle of internal audit
 The role of internal audit
 Quality audit documentation
b. Managing the internal audit program
 Process flow for the management of an audit program
 Authority for internal audit program
 Establishing the audit program
 Audit program implementation
 Monitoring and reviewing the audit program
c. Audit activities
 Overview of audit activities
 Initiating the audit
 Conducting document review
 Preparing for on-site audit activities
 Conducting on-site audit activities
 Preparing, approving, and distributing the internal audit report
 Completing and conducting audit follow-up
d. Conclusion
e. References
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INTRODUCTION
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OBJECTIVES

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To define the activities and requirements of IA
 To identify the roles and benefits of IA in a
quality management system
 To learn how to plan, perform and monitor IA
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DEFINITION




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“Internal Audit" is an independent examination of
a quality system
It measures the effectiveness of an organisation's
quality management system.
It is a documented and systematic tool
It should be done periodically by independent and
qualified people

“Audit" itself is a checking system, NOT a
quality assessment

As a communication tool of management policies.
All personnel have to understand and do their jobs
well
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ROLES OF IA

As a powerful tool to measure the effectiveness
of quality management system

Evaluates manufacturer’s compliance with GMP
in all aspects related production and quality
control

Detects any shortcomings in the implementation
of GMP

Recommend the necessary corrective and
preventive actions
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SCOPE OF IA (1)

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Ensures quality in design, approval,
monitoring and evaluation of products should
comply GMP requirements
 Ensures quality in GMP implementation and its
strategies
 Ensures quality in appointment, development
and performance of staff and key personnel
 Ensures quality in obtaining and responding to the
feedbacks from customers, consumers, employers,
employees, government authority and other
relevant institutions
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SCOPE OF IA (2)

Includes all written quality documents,
instructions and records

Covering all elements of GMP including results
of previous internal quality audit and any
corrective and preventive actions (CAPA) taken
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BENEFITS OF IA

Tells you the health of a quality system

Identify the root of a problem and plan for
corrective and preventive actions with timeline

Achieve better allocation of resources

Able to avoid potentially big problem

Learn what an auditors look for

Continuous improvement
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KEY PRINCIPLES OF IA
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Approaches towards IA:
• Independent
• Evidence-based approach
All activities related to IA should:
• be reviewed by an independent party
• be a self-appraisal system
• have a sampling plan and tracking system
• be open, constructive and effective
Strategies in conducting audit:
• Ask with the basic audit questions about the quality
system in place
• Start with what, why, how, who, where, when
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PRINCIPLE OF AN AUDITOR
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 Ethical
 Professional
 Fair
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GUIDANCE WHEN CONDUCTING AN AUDIT
•
Auditing should be seen as a positive process not a
fault finding
•
Audits need to be documented
•
Prior to the audit date, an auditor needs to review
the quality system documentation, corrective and
preventive actions, and past audit findings and
develop a checklist
•
During an audit, an auditor need to see evidences
that the processes are being done in accordance to
procedures and policies
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GUIDANCE FOR AUDITEE
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When being audited:
•
•
•
•
•
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Volunteer information
Report deficiencies and difficulties if you know of any
Be honest, open and cooperative
Ensure that underlying causes are identified
Ask the auditor if you’re not sure
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MANAGING IA
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FLOW CHART OF IA
Authority for the audit
programme
Establishing
the internal audit program
obectives
responsibilitties
resources
procedure and guidance
Act
Improving the audit
programme
Implementing internal audit program
scheduling audits
evaluating auditors
selecting audit team
directing audit activiries
maintaining records
Plan
competence and
evaluation of
auditors
Audit activities
Monitoring & reviewing
the internal audit program
monitoring & reviewing
identifying needs for corrective
identifying needs for prevention actions
identifying opportunities for improvement
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Do
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Check
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RESOURCES FOR IA
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Considerations should be given to the following:





Resources
Audit techniques
Processes to achieve and maintain the competency of
auditors and to improve their performance
Competency and availability of auditor
Available time for auditing
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IA
OBJECTIVES
PLANNING
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The planning of IA consists of :
•
Authority for administering the IA program
• Establishing IA program



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Objectives
Responsibility
Procedure and guidance
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IA IMPLEMENTATION
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The implementation of IA program
consists of :



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Scheduling audit
Implementation of audit program
Audit record and report
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IA MONITORING
•
•
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Implementation of audit program should be
monitored at appropriate intervals and reviewed
to assess whether its objectives have been met
and identified opportunities for improvement.
Auditing findings should be reported to the
management.
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AUDITING ACTIVITIES
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OVERVIEW OF AUDIT ACTIVITES
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Planning and scheduling audit
Conducting document review
Preparing for on-site activities
Conducting audit
Prepare audit report
Conducting follow-up
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AUDIT ACTIVITIES
•
Forming an audit team and assign roles and
responsibility and agreed on the scope
•
Conducting document review
 Review documents (SOPs, audit findings,
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corrective action/preventive action, etc.),
check the integrity of the quality system
and various controls are effective
•
Preparing for the on-site audit activities
 Preparing audit plan
 Assigning work to the audit team
 Preparing work documents
(eg. audit checklists, sampling plans, forms for
recording information; questionnaires)
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AUDIT DOCUMENTATION
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• Audit plan
 should be sent to auditee prior to audit
activity
 findings from the last audit should be also
mentioned
• Audit note should include
 an audit questionnaire
 all records and comments during the audit
•
Audit report is an
 official document to report the audit findings
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EXAMPLE OF AN AUDIT CHECKLIST
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General format for an audit checklist
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EXAMPLE OF AN AUDIT CHECKLIST
Date
Auditor
CHECKING LIST FOR GMP ASSESSMENT
DESCRIPTION
Personnel
:
:
Location
Auditee
Storage area
GMP.REF.
1.2.1
5.1.2
2.1.5
10.1.1
3.1
3.6
3.9 & 3.10
3.12.2
Sanitation
3.1
5.3
Documentation
4.3
10.2.2.3
10.2.2.1
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PARAMETER
- Organization structure
- Personnel hygiene
- Training record
- Design and layout of defined area
- Flow of personnel and goods
- Structure of the storage area, based
on GMP
- HVAC system
- Record of monitoring parameter
- Pest record program
- The map of bait
- The cleanliness of weighing
apparatus
- Record of maintenance and
calibration of weighing apparatus
- The effectiveness of label system
- Inventory stock control
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: Warehouse
:
AUDIT FINDING
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IA MONITORING
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INTERNA: AUDIT QUESTIONAIRES
Area audited : ______________________
Date: __________________
Question (QSR-GMP Reference)
Response
1. Does the company have a work instruction to
operate the machine?
2. How is the machine being cleaned and
maintained?
3. Are personnel trained to use the machine?
4. How often is the equipment being calibrated
and cleaned?
5. When is the last breakdown of the machine?
Are there any product being affected?
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AUDITING ACTIVITIES (1)
•
Conducting on-site audit activities

Conduct opening meeting

Good communication during the audit

Roles of escort and observer

Steps in conducting on site audit:



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Interviews with different personnel
Carry out both horizontal and vertical audits.
Focus on safety and quality of product.
Use “Trace-back” method
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AUDITING ACTIVITIES (2)
•
Generating audit findings
 Either conformity or non-conformity
 Sort out isolated or systemic
deficiencies
Isolated deficiency:
Tends to happen randomly; no meaningful
pattern; rarely happens
Systemic deficiency:
Could be connected to a particular process,
product, material, person or organisation; shows
pattern; happens more than once
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ISOLATED VERSUS SYSTEMIC DEFICIENCY
NON CONFORMANCE DEFICIENCIES
ISOLATED
SYSTEMIC
Latex gloves rip
SOP contains an error
Wrong expiration date written on a
reagent bottle
Batch record is poorly written so
instruction can be confusing
Operator or lab technician spills a
sample
Area management does not reinforce
requirement to continually record
information properly
Pressing machine of eye shadow
burns out
Preventive maintenance program does
not include liquid filling machine motor
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AUDIT MONITORING
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The audit finding can be classified into 2 groups:
1. Compliance :
a. Satisfactory /Adequate
b. Outstanding
2. Non-compliance :
a. Critical deficiency
b. Major deficiency
c. Minor deficiency
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AUDIT REPORT






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Objectives
Audit scope
Identification of audit team leader and
members
Date and place where the on-site audit
activities were conducted
Audit criteria and findings
Conclusions
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AUDIT REPORT






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Various formats can be used depending on auditee
(vendors, management or auditee)
Usually include name and location of auditee, date
of audit, audit plan, audit observations,
classification of non-compliances, recommendations
or expectations
Should write against a standard
Focus on deficient conditions and not people
Include any positive observations
Keep the audit report simple and clear
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AUDIT REPORT: AN EXAMPLE
No
GMP.Ref
Findings of IA
1.
2.1.1
Production and QC
departments are
headed by the
same person
Critical
Human
Resources
Abas
Budi
2.
4.3
Monitoring of
temperature in a
warehouse
Major or
Minor
Warehouse
Tuti
May Lin
3
11.1
Inadequate control
over sub-contractor
Major or
Minor
Production
Herman
Ida
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Grading
Location
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Auditee
Auditor
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CLOSURE
Follow-up and closing of loop:
•
Receive a satisfactory response from auditee and
their commitment to correct for any deficiency
•
Ensures CAPA identify the root cause and they are
satisfactory, accomplished and documented
•
Timeframe for CAPA is being followed
•
Verify and track CAPA by scheduling a follow-up audit
and/or requesting for an updated SOP
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CONCLUSIONS
Nobody likes to be
audited………..
It is a means to have
continuous improvement
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RELATED HYPERLINK DOCUMENTS
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 Trainer Manual of Internal Quality Audit
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REFERENCES
1.
2.
3.
4.
5.
6.
7.
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for Standardization
Implementing Agency
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ASEAN Guidelines for Cosmetic GMP.
International standard ISO 9001:2002,
Guidelines for quality and/or environmental
management system auditing, 1st Edition, 2002
www.cityu.edu.hk, Internal Quality Audit Scheme.
www.fineprint.com, Internal Audit Procedure
Stimson W.A., Internal Quality Auditing, Meeting
the challenge of ISO 9000:2000, Paton Press,
2001
WHO – EDM, Basic Principle of GMP: SelfInspection.
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